UKPAR for Ibuprofen 10% w-w gel, Nurofen …

1 UKPAR Ibuprofen 10 % w/ w gel , Nurofen maximum strength 10 % Gel PL 10972/0089 1 Ibuprofen 10% w/ w gel Nurofen maximum strength 10 % Gel PL 10972/0089 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of Product Characteristics Page 12 Product Information Leaflet Page 16 Labelling Page 18 UKPAR Ibuprofen 10 % w/ w gel , Nurofen maximum strength 10 % Gel PL 10972/0089 2 Ibuprofen 10% w/ w gel Nurofen maximum strength 10 % Gel PL 10972/0089 LAY SUMMARY On 27th July 2012, the MHRA granted Marketing Authorisation (licence) for the medicinal product Ibuprofen 10% w/ w gel , Nurofen maximum strength 10 % Gel (PL 10972/0089).

2 This is a pharmacy medicine (P). Nurofen maximum strength 10% Gel contains Ibuprofen and belongs to a group of medicines called non-steroids anti-inflammatory drugs (NSAID s). These medicines, used on the skin, reduce pain and inflammation. Nurofen maximum strength 10% Gel is used to treat a number of painful conditions affecting the joints and muscles, such as backache, rheumatic and muscular pain, sprains, strains and sports injuries. It is also used for the relief of pain caused by non-serious arthritic conditions and nerve pain (neuralgia).

3 No new or unexpected safety concerns arose from this application and it was, therefore, judged that the benefits of taking Ibuprofen 10% w/ w gel , Nurofen maximum strength 10 % Gel outweigh the risks; hence Marketing Authorisation has been granted. UKPAR Ibuprofen 10 % w/ w gel , Nurofen maximum strength 10 % Gel PL 10972/0089 3 Ibuprofen 10% w/ w gel Nurofen maximum strength 10 % Gel PL 10972/0089 SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 4 Pharmaceutical assessment Page 5 Non-clinical assessment Page 8 Clinical assessment Page 9 Overall conclusions and risk benefit assessment Page 10 UKPAR Ibuprofen 10 % w/ w gel .

4 Nurofen maximum strength 10 % Gel PL 10972/0089 4 INTRODUCTION The Medicines and Healthcare Products Regulatory Agency (MHRA) granted marketing authorisation (licence) for the medicinal product Ibuprofen 10% w/ w gel , Nurofen maximum strength 10 % Gel (PL 10972/0089) to Goldshield Group Limited on the 27th July 2012. This medicine is used for the relief of pain and inflammation associated with backache, rheumatic and muscular pain, strains, sprains, neuralgia, sports injuries and for the relief of pain of non-serious arthritic conditions.

5 This application was submitted as abridged application according to Article 10c of Directive 2001/83/EC as amended, cross-referring to Fenbid Forte 10% gel (PL 10972/0082), held by Goldshield Group Limited, which was granted marketing authorisation on 5th January 1999. No new data were submitted nor were they necessary for this simple application, as the data are identical to those of the previously granted cross-reference product. As the cross-reference product was granted prior to the introduction of current legislation, no Public Assessment Report (PAR) was generated.

6 A pharmacovigilance system has been provided with this application and is satisfactory. A suitable justification for non-submission of the Risk Management Plan has been provided. No environmental risk assessment (ERA) has been undertaken, as this is not considered necessary. This product is essentially similar and the therapeutic indications and posology of the finished product are the same as those already licensed products. The applicant s justification for absence of ERA is satisfactory. UKPAR Ibuprofen 10 % w/ w gel , Nurofen maximum strength 10 % Gel PL 10972/0089 5 PHARMACEUTICAL ASSESSMENT LICENCE NO: PL 10972/0089 PROPRIETARY NAME: Ibuprofen 10% w/ w gel , Nurofen maximum strength 10 % Gel COMPANY NAME: Goldshields Group Limited ARTICLE: Article 10c of Directive 2001/83/EC LEGAL STATUS: P 1 INTRODUCTION This is an informed consent application for Ibuprofen 10% w/ w gel , Nurofen maximum strength 10 % Gel, submitted under Article 10c of Directive 2001/83/EC as amended.

7 This product is cross-referring to Fenbid Forte 10% gel (PL 10972/0082), approved on 5th January 1999 to the marketing authorisation holder, Goldshield Group Limited. The current application is considered valid. 2 MARKETING AUTHORISATION APPLICATION (MAA) Name(s) The proposed names of the product are Ibuprofen 10% w/ w gel , Nurofen maximum strength 10 % Gel. The product has been named in line with current requirements. strength , pharmaceutical form, route of administration, container and pack sizes The product is a gel for topical use and contains the active ingredient Ibuprofen .

8 The product is packed in collapsible aluminium tubes with internal protective lacquer with HDPE screw caps. Pack sizes of 30g and 50g. The packaging and pack sizes are the same as those for the reference product. The proposed shelf life is 36 months with a storage conditions Do not store above 25 C and Keep the tube in the outer carton in order to protect from light . The shelf-life and storage conditions are identical to those for the reference product and are satisfactory. Legal status This product is supplied through Pharmacy (P).

9 Marketing authorisation holder/Contact Persons/Company The proposed Marketing Authorisation holder is Goldshield Group Limited, (trading as Goldshield Pharmaceuticals), NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT, UK Manufacturers The proposed manufacturing sites are consistent with those registered for the reference products and evidence of Good Manufacturing Practice (GMP) compliance has been provided. UKPAR Ibuprofen 10 % w/ w gel , Nurofen maximum strength 10 % Gel PL 10972/0089 Qualitative and quantitative composition The proposed composition is consistent with the details registered for the referenced product.

10 Manufacturing process The proposed manufacturing process is consistent with the details registered for the referenced product and the maximum full scale batch size is stated. Finished product/shelf-life specifications The proposed finished product and shelf-life specification are in line with the details registered for the referenced product. Drug substance specificatio The proposed drug substance specification conforms to the current European Pharmacopoeia monograph for Ibuprofen and is in-line with those for the referenced product.